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Lower risk Medical device recall · FDA · Published June 17, 2025

Microbiologics KWIK-STIK and LYFO DISK recall: Quality control failure risk

Microbiologics recalls KWIK-STIK and LYFO DISK culture media kits due to potential quality control failure causing delayed patient diagnosis. Affected lots include 805-234-4 and 805-234-5.

🇺🇸 FDA recall #Z-2124-2025Medical deviceMicrobiologics ›
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Recalling firmMicrobiologics Inc200 Cooper Ave N · Saint Cloud, MN 56303-4440
✎ GovInfoNow plain-language explainer

Microbiologics is recalling KWIK-STIK and LYFO DISK culture media kits because they contain the wrong bacteria (Staphylococcus epidermidis instead of Brevundimonas diminuta). This could cause quality control tests to fail, leading to delayed diagnosis for patients. Read more at govinfonow.com/recall/52033-microbiologics-kwik-stik-and-lyfo-disk-recall-quality-control-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/52033-microbiologics-kwik-stik-and-lyfo-disk-recall-quality-control-failure · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2124-2025

Cite this page

“Microbiologics KWIK-STIK and LYFO DISK recall: Quality control failure risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52033-microbiologics-kwik-stik-and-lyfo-disk-recall-quality-control-failure. Based on FDA recall #Z-2124-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2124-2025%22&limit=1).

The FDA announced on June 17, 2025, that Microbiologics Inc is recalling KWIK-STIK and LYFO DISK quality control kits due to contamination with Staphylococcus epidermidis. The agency stated the error may cause quality control failure and delayed patient diagnosis.

How to tell if you have it

  • Brand: Microbiologics
  • Product: KWIK-STIK and LYFO DISK, quality control kit for culture media
  • Catalog #: 0805K and 0805L
  • Lot #: 805-234-4, 805-234-5
  • UDI: (0805K) 30845357019531, (0805L) 10845357019544
  • Distribution: US (Utah, Ohio) and international (Italy, Netherlands, Argentina, Korea, Jordan, Spain, Bangladesh)
  • Units affected: 21 total

The hazard

Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.

Context

GovInfoNow's records show Microbiologics Inc has 35 other recalls on record since June 6, 2017. Other recent recalls of similar products include Microbiologics KWIK-STIK 2-Pack (Dec. 2, 2025), Microbiologics KWIK-STIK Quality Control Kit (Nov. 13, 2025), and Microbiologics LYFO-DISK (June 27, 2025). Other recent recalls of similar products include Medline Blood Culture Kit (Dec. 24, 2025), Medline Convenience Kits (June 12, 2026), and Medline Convenience Kits (Aug. 11, 2026).

How to tell if you have this one

Check for catalog numbers 0805K or 0805L on the kit packaging. Affected lots include 805-234-4 and 805-234-5. The unique device identifier (UDI) for 0805K is 30845357019531 and for 0805L is 10845357019544.

  • Brand
    Microbiologics
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for catalog numbers 0805K or 0805L on the kit packaging and check the lot numbers 805-234-4 or 805-234-5.

Where it went and when

Where it was distributed

Distributed in Ohio and Utah, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: yesUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Ohio, Utah.

Recall timeline

FDA published this recall 36 days after the firm started it.

1. Firm started the recall: Jun 17, 202512. FDA classified it Class II: Jul 17, 202523. Published in FDA’s Enforcement Report: Jul 23, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2124-2025 (June 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2124-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA